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RO7837195 · 1 trial · 1 indication
Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.
| Arm | Type | Description |
|---|---|---|
| RO7837195 Dose Regimen 1 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Dose Regimen 2 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Dose Regimen 3 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Dose Regimen 4 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Matched Placebo/ RO7837195 | EXPERIMENTAL | Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively. |
| Name | Type | Description |
|---|---|---|
| RO7837195 | DRUG | RO7837195 will be administered as per the schedule specified in the protocol. |
| RO7837195 Matched Placebo | DRUG | RO7837195 matched placebo will be administered as per the schedule specified in the protocol. |
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established at least 3 months * Moderately to severely active UC assessed by mMS * Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC Exclusion Criteria: * Prior extensive colonic resection,...
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RO7837195 is an investigational small molecule being developed for the treatment of moderately to severely active ulcerative colitis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
RO7837195 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with ulcerative colitis.
RO7837195 is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. A Phase 2 trial is currently recruiting participants with moderately to severely active ulcerative colitis.
RO7837195 is being studied in one Phase 2 trial, NCT06979336, which is recruiting 224 participants with moderately to severely active ulcerative colitis. The study is randomized, double-blind, and controlled, and is being conducted across multiple countries.
RO7837195 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for ulcerative colitis. The drug has not completed clinical development or received marketing authorization from regulatory agencies.